The Harmony test analyzes cell-free DNA circulating in maternal blood, which allows a high level of accuracy for detecting fetal trisomies, such as trisomy 21 that causes Down syndrome. Ariosa is expanding the clinical indications for the Harmony test to include all IVF singleton pregnancies, including unrelated egg donor and surrogate pregnancies.

The expanded Harmony test for IVF pregnancies will be available in the United States, as well as in several international markets. In 2012, Ariosa entered the European market as the first non-invasive prenatal test in the United Kingdom. Ariosa is now expanding throughout Europe,the Middle East, Australia, and Latin America.

“We are focused on identifying those test enhancements which can provide clear clinical utility,” said Ariosa CEO Ken Song, MD. “The Harmony test represents a major clinical advance to provide reliable and accurate information to pregnant women, and we are committed to making this test available globally.”

*The Harmony Prenatal Test is developed by Ariosa Diagnostics. Ariosa Diagnostics is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). As with other laboratory-developed tests, this testing service has not been cleared or approved by the US FDA or any other federal regulatory agencies.Non-invasive prenatal testing (NIPT) services based on cell-free DNA analyses are not diagnostic; results should be confirmed by diagnostic testing.Data have not been submitted to or evaluated by Federal regulatory agencies and the test is not for sale as an In Vitro Diagnostic (IVD) in the US or the EU.